Congenital Heart Disease
Conditions
Brief summary
Coagulation abnormalities after pediatric open-heart surgery are complex and very often multifactorial. Besides the cardiopulmonary bypass (CPB), the congenital pathology and the coagulation tests during CPB, the younger age has been the most significant risk factor for bleeding and transfusion requirements. In children the volume of pump priming is much higher compared with the patient's circulating blood volume. For this reason the CPB tubing system is primed with packed red blood cells and fresh frozen plasma (FFP) to avoid excessive hemodilution and induced coagulopathy. While this is routinely performed in neonates and small infants, the routine priming of CPB system with FFP has been questioned in several randomized prospective studies in older infants. However, the results of these studies are conflicting. Moreover, they show methodological issues.
Interventions
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Months to 70 Months
Healthy volunteers
No
Inclusion criteria
* Children weighing between 7 and 15 kg and admitted to undergo open-heart surgery with CPB
Exclusion criteria
* Patients with preoperative coagulation abnormalities * Parental refusal * Emergency surgery * Patients with preoperative renal or hepatic dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative bleeding (mL blood in the chest tubes). Significant postoperative bleeding is defined as a bleeding of > 5ml/kg/h in the first 6hours postoperatively. | The first 6 hours postoperatively | The exact amount of blood loss in the postoperative period per kilogram weight of child. |
| Increased risk of of donor exposure intraoperatively and postoperatively. | The first 6 hours postoperatively | The total number of different packs of allogeneic blood products administered per child. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of transfused allogenic blood products (mL). | The first 6 hours postoperatively | The total volume of allogeneic blood products per kilogram weight of child. |
| Comparison of Rotem and Multiplate between both groups. | The first 6 hours postoperatively | The results of the point-of-care tests ROTEM and Multiplate will be compared between children in the Plasmalyte group and children in the Fresh Frozen Plasma group. |
Countries
Belgium
Outcome results
None listed